It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards of safety and quality for most medical devices. However this expected to change with the introduction of the Medical Device Rules, 2017 which is expected to take effect from January 1st, 2018.

Currently there are certain medical devices which are regulated by deeming these devices as “drugs” and thus they are regulated under the Drugs and Cosmetics Act, 1940. These medical devices are referred to a “Notified Medical Devices” and they

As the article states the Act and DC Rules seek “to regulate the import, manufacture, distribution and sale of Notified Medical Devices and ensure the availability of standard quality Notified Medical Devices to the consumer.

The list of Notified Medical Devices includes:
1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HBsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic replacements
15. Ablation Devices

I’ll be interested to see what the “Medical Device Rules” will be, which will come into effect Jan 1, 2018.